Know Cancer

forgot password

Postoperative Lymphedema Treatment in Upper Extremities Following Axillary Lymphadenectomy by Transplanting Autologous Endothelial Progenitor Cells (EPC)

Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Lymphedema, Breast Cancer

Thank you

Trial Information

Postoperative Lymphedema Treatment in Upper Extremities Following Axillary Lymphadenectomy by Transplanting Autologous Endothelial Progenitor Cells (EPC)

Phase 1:

The procedure will be as follows:

10 patients were recruited in the General Surgery or Oncology meeting the inclusion
criteria. During the study, patients can´t use any other kind of treatment for the

Visit 1: We explain the procedure by inviting patients to participate after signing informed
consent. There will be a complete medical history, review of inclusion and exclusion
criteria, signing a letter of informed consent, be requested general laboratory tests (blood
count, biochemical profile), tele-ray.

Visit 2: Initiation colony stimulating factor (Filgrastim SC) to 300 micrograms per day for
3 consecutive days.

Visit 3: Conduct a puncture and bone marrow harvesting under local anesthesia of the
posterior iliac crest with Jamshidi needle to aspirate (approximately 50 - 100ml). The
product obtained will be centrifuged in a refrigerated centrifuge at 3500 Sigma EK15 ®
rpm/15 minutes to 8 ° C with HES 6% (pentastarch 6g/100ml) to obtain the mononuclear cell
layer. Once the cells were obtained will be transported to the operating room to manage the
patient by intramuscular injection of 0.5 to 1 ml in 30 to 50 sites of the affected limb
with a depth of about one centimeter, using a needle number 25. The administration will take
place in the operating room under local anesthesia or sedation if necessary.

Visit 4 and subsequent: clinical evaluation will be conducted each week, especially data
monitoring of infection in the puncture sites. At week 12 post-cell infusion, the latest
revision will be made and carried out measurements in both arms to conclude and determine
the outcome of treatment.

Phase 2 (Control group):

Another 10 patients with lymphedema will be included in a 6 week study to compare the most
common treatment of the lymphedema, the compressed sleeves.

Visit 1: A complete medical history will be performed. A compression sleeve will be given to
the patients for their use during the next 2 weeks.

Visit 2 and 3: On week 2 and 3 of the compression sleeve treatment, the patients will be
measured in both upper extremities as well as assess the symptoms or not that patients

Visit 4 and 5: Patients will stop using the compression sleeve treatment for the next 2
weeks measured both upper extremities and interrogate patients about symptoms during this

Visit 6 and 7: The last 2 weeks of the study patients will be asked to restart the
compressed sleeves treatment and measured both upper extremities and interrogate patients
about symptoms presented during this stage of the study.

Inclusion Criteria

Inclusion criteria:

- Patients with postsurgical lymphedema in upper extremities following axillary

- Female gender.

- Age over 18 years.

- Patients who wish to participate in the study.

- Informed consent signed.

Exclusion criteria:

- Patients with hypercoagulable states.

- Patients with a history of obstructive vascular disease in the brain, kidneys or

- Patients with congestive heart failure (ejection fraction less than 30%)

- Active infectious process, serious, anywhere in the body.

- Patients over 75 years of age.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine if the stem cells are effective in patients with lymphedema with the decreased of the volume of the affected limb and improvement of the symptomatology.

Outcome Description:

Patients will be measured in 4 different areas of both arms with a tape measure, before the transplant and weekly after the transplant for 3 months. Measure 1: 10 cm over the epicondyle. Measure 2: 5 cm over the the epicondyle. Measure 3: 5 cm under the the epicondyle. Measure 4: 15 cm under the the epicondyle Also a questionnaire of the most common symptoms will be given to the patients to mark their own symptoms before the transplant and 3 months after the transplant.

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Gerardo E. Muñoz Maldonado, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Universitario Dr Jose Eleuterio Gonzalez


Mexico: Ethics Committee

Study ID:




Start Date:

September 2009

Completion Date:

September 2010

Related Keywords:

  • Lymphedema
  • Breast Cancer
  • Lymphedema
  • Stem cells
  • Mastectomy
  • Breast Cancer
  • Breast Neoplasms
  • Lymphedema